Carlesso Lisa C, Macdermid Joy C, Santaguida P Lina, Thabane Lehana
Department of Clinical Epidemiology and Biostatistics.
School of Rehabilitation Sciences, McMaster University, Hamilton ; Clinical Research Lab, Hand and Upper Limb Centre, St. Joseph's Health Centre, London, Ont.
Physiother Can. 2013 Summer;65(3):255-65. doi: 10.3138/ptc.2012-28.
To pilot and determine the feasibility of estimating adverse events in patients with neck pain treated with cervical manipulation/mobilization by Canadian orthopaedic manual physiotherapists (OMPTs) using an online data-collection system to provide estimates for a future larger multi-centre international study.
In a prospective multi-site two-group cohort study, participants received usual care and either (a) combined manipulation and mobilization or (b) mobilization only. Study feasibility objectives and criteria for success were set a priori. Data were analyzed using descriptive statistics.
A total of 20 patients were recruited from 6 of 16 participating centres, 17 to the mobilization group and 3 to the combined group. Barriers to data collection included low recruitment, difficulties in using the online data-collection system, and clinicians' and patients' being too busy to participate. Missing data for the primary outcome averaged 28.5%. A total of 69 symptom occurrences were reported during the treatment phase, all benign and transient. Most began within 0-12 hours after treatment (66/69, 95.6%) and lasted for 0-2 days (56/69, 81.2%). Kappa estimates of agreement between therapists and patients on reporting of adverse symptoms across visits 1-5 was substantial (κ=0.68; 95% CI, 0.52-0.84; p<0.01).
This pilot study demonstrates substantial challenges in conducting a large multi-centre trial. Brief, benign, and transient adverse events were common; no substantial adverse events were observed.
通过在线数据收集系统，对加拿大骨科手法物理治疗师（OMPTs）采用颈椎整复/松动术治疗颈部疼痛患者的不良事件进行初步评估，并确定其可行性，以便为未来更大规模的多中心国际研究提供评估数据。
在一项前瞻性多中心两组队列研究中，参与者接受常规护理，并分为两组：（a）联合整复与松动术组；（b）仅松动术组。预先设定研究可行性目标和成功标准。采用描述性统计方法分析数据。
从16个参与中心中的6个中心共招募了20名患者，其中17名进入松动术组，3名进入联合组。数据收集的障碍包括招募率低、使用在线数据收集系统困难，以及临床医生和患者太忙而无法参与。主要结局的缺失数据平均为28.5%。在治疗阶段共报告了69次症状发作，均为良性且短暂性。大多数症状在治疗后0 - 12小时内开始（66/69，95.6%），持续0 - 2天（56/69，81.2%）。治疗师与患者在第1 - 5次就诊时关于不良症状报告的kappa一致性估计较高（κ = 0.68；95% CI，0.52 - 0.84；p < 0.01）。
这项初步研究表明，开展大型多中心试验面临重大挑战。短暂、良性和短暂性不良事件很常见；未观察到重大不良事件。
